2,277 recalls · Class II, newest first
Reason CGMP Deviations: Potential exposure to rodents and rodent activity in the distribution center.
Reason Labeling - product contains undeclared ethyl alcohol
Reason Labeling - product contains undeclared ethyl alcohol
Reason Failed Tablet Specifications: Recall of this drug product was voluntarily initiated by the manufacturer due to a market complaint, which stated that…
Reason Subpotent Drug: FDA analysis has revealed some bottles of these products were sub potent for ethanol.
Reason Subpotent Drug: FDA analysis has revealed some bottles of these products were sub potent for ethanol.
Reason CGMP Deviation: Difficulty dispensing/does not dispense or dispensing liquid instead of foam.
Reason Lack of Assurance of Sterility
Reason MICROBIAL CONTAMINATION OF NON-STERILE PRODUCT: microbial contaminant identified as Pluralibacter gergoviae.
Reason Superpotent Drug: Minimally superpotent
Reason Defective container: Out of specification for container integrity leading to bottles leaking.
Reason Labeling; Label mix-up and Wrong Bar Code; back label incorrectly states active ingredient as Menthol with UPC 7 14132 00071 4 instead of Peppermint…
Reason Labeling: Incorrect Instructions
Reason CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
Reason CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
Reason CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
Reason CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
Reason Failed Stability Specifications; out of specification for shear.
Reason Failed Stability Specifications; out of specification for shear.
Reason Defective container: possibility for lack of seal integrity.
Reason Marketed without ANDA/NDA approval
Reason cGMP Deviations
Reason cGMP Deviations
Reason cGMP Deviations
Reason cGMP Deviations